PB0412 - The use of rivaroxaban in the treatment of pediatric thrombotic events: a single-center experience

Background: Direct oral anticoagulants (DOACS) are recently approved to be used in children for the treatment of venous thromboembolic events (VTE). Although the safety and efficacy of these agents are confirmed in multicenter clinical trials, the real-world experience data need to validate this approval.

Aims: We decided to share our experience with using rivaroxaban in the treatment of pediatric VTE in Shiraz, Southern Iran.

Methods: We reviewed the electronic files of 93 children (0-18 years) from September 2016 to January 2024 with proven VTE.

Results: The mean age (SD) of the enrolled patients was 7.52 (5.81) years, and 51 (54.8%) were female. We encountered 98 thrombotic events in 93 children of which 79 (80.6%) were venous thrombosis. The most common sites of thrombosis were the lower extremities (34.2%), cerebral sinovenous (24.1%), and portal vein (15.2%). The majority of VTEs (85%) were provoked. The most common risk factors were central vein catheters (17.2%) followed by malignancy (14%). Ten patients (10.8%) had multiple risk factors.
Thirty-eight patients were treated with rivaroxaban of which 34 patients completed their treatment course (Table 1). Four patients had to discontinue the drug due to massive gastrointestinal bleeding from esophageal varice, elevated liver enzymes, painful skin necrosis, and recurrent VTE. Two adolescent girls experienced heavy menstruation. A boy with leukemia in remission had to decrease the drug dosage due to thrombocytopenia and nose bleeding. One patient with metastatic neuroblastoma and deep vein thrombosis died of his malignancy which was unrelated to DOAC use.

Conclusion(s): Rivaroxaban is safe and effective in the treatment of VTE in children. The adverse effects are usually mild, and most of the patients tolerated the drug and completed the planned course of treatment.